FDA Inspection
Simmler IncSimmler Inc – FDA Inspection, Mar 2, 2012
Record Details
This FDA Inspection record concerns Simmler Inc, with an inspection on March 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Simmler Inc
- Inspection Date
- March 2, 2012
- Product Type
- Devices
View Company Profile
ID · 7d59d768-a5df-4acf-b104-9079bb48de5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770456
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Simmler Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Simmler Inc
- FDA Inspection 1277698 - 2025-08-05
- FDA Inspection 1176576 - 2022-07-20
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